EC approves Venclyxto-based combo for acute myeloid leukemia

26 May 2021

The European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

Venclexta/Venclyxto is being developed by USA-based AbbVie (NYSE: ABBV) and Swiss pharma giant Roche (ROG: SIX). It is jointly commercialized by AbbVie and Roche subsidiary Genentech in the USA, and commercialized by AbbVie outside of the USA. The drug generated first quarter 2021 sales of $405 million for AbbVie, of which $225 million came from the USA.

“This Venclyxto approval is a critical step in providing new therapeutic options for patients in the EU newly diagnosed with AML who cannot tolerate the side effects of, or are ineligible for, intensive chemotherapy,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development.

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